Justice Zondi’s careful and deliberate judgment in the Cape High Court case brought by the Treatment Action Campaign (TAC) and South African Medical Association (SAMA) against Dr Matthias Rath and others, has several interesting consequences.

The main issues in the case were whether or not Dr Rath had been conducting unauthorised clinical trials, whether or not he was selling a medicine (or a foodstuff), and whether or not he had been publishing misleading or false advertisements.

The results: Dr Rath and others had been conducting an unauthorised clinical trial and were interdicted from carrying out studies in South Africa; they were selling a medicine and not a foodstuff as they had claimed (and were “selling” it as defined by the Medicines Act); and that the Medicines Control Council (MCC) would have to assess the advertising claims of Dr Rath’s Vitacell product.

There are gaps that were not and could not have been addressed by the judgment. The first of these is why the Department of Health Inspector, Lionel Snyman, was prematurely pulled off the job of inspecting Dr Rath and his activities. Speculation that he had recommended that Dr Rath be arrested, or that he had uncovered possibly embarrassing information, is not unreasonable.

André du Toit, a manager and co coordinator of law enforcement activities amongst other duties for the national department of health, was apparently appointed in Snyman’s place. Judge Zondi found du Toit to have not “sufficiently” investigated the matter of Dr Rath’s carrying out unauthorised clinical trials. Inspectors from the Department of Health are appointed by the Director General in terms of the Medicines Act and answer directly to the DG. An anomaly is that these inspectors are seemingly not obliged to report to the MCC itself. Judge Zondi’s judgment states that neither the DG nor Mr du Toit furnished information as to the nature and extent of the investigation carried out by du Toit. This is rather disturbing.

Towards the end of 2005 the then Registrar of the MCC, Dr Humphrey Zokufa, had promised to make the results of the investigation into Dr Rath’s activities available to the media within six weeks following a request which had been made for them. I do not know if this ever happened. However as the DG was the senior official, the promise made by the Registrar may well have not been honoured.

There are several complementary medicine products on the market that have been tested on human beings in South Africa seemingly without obtaining the required authorisation. Judge Zondi referred to a definition of clinical trial that was used in the Supreme Court of Zimbabwe in 2002. He did not accept that a “clinical pilot study” was not a clinical trial, but indicated that in characterising it as such, Dr Rath and others appeared to have been attempting to escape liability for their own widely proclaimed conduct.

The Minister of Health wrote that she would “only distance myself from Dr Rath if it can be demonstrated that the vitamin supplements that he is prescribing are poisonous for people infected with HIV.” She was probably using the word “prescribing” generically as it appears Dr Rath is not registered to practice in South Africa, and may therefore not prescribe medicines here. Poison(ous) is a word which has previously been used in South Africa to describe antiretroviral medications. I can find no record of anyone making assertions that Dr Rath’s vitamin supplements were “poisonous”. But by then there were already allegations of his conducting an illegal clinical study, and of undermining government’s own HIV and Aids comprehensive care, management and treatment plan, which includes the provision of antiretroviral therapy to the public sector. Will the Minister now distance herself from Dr Rath, seeing that he has been found by a court of law to have unlawfully been conducting a clinical trial?

The judgment has determined that the vitamin supplements referred to are a medicine (and not a foodstuff) in terms of the Medicines Act, and that the claims made for them are to be assessed by the MCC before they can be advertised. The judgment leaves it up to the MCC to decide whether or not Dr Rath’s products should be registered, and/or whether they should be scheduled.

Although guidelines are not law, the MCC’s own published guidelines (www.mccza.com) state that any product containing a scheduled substance is liable for registration. The judgment confirmed that Dr Rath’s product Vitacell contains a scheduled substance: N-acetylcysteine, which is a Schedule 2 substance. This means that it cannot be made available in an open shop, but only in a pharmacy or a registered health facility. The MCC should not have much difficulty deciding that Dr Rath’s Vitacell is liable for registration according to its own guidelines, even though Judge Zondi does not think it needs to be registered.

Judge Zondi however does not distinguish between a medicine and a “substance”. Individual substances are scheduled; medicines fall within a schedule according to the substances contained in them. Most medicines contain combinations of active and inactive ingredients or substances, some of which may be scheduled. Scheduling determines where a medicine may be sold, whether or not a doctor’s prescription is required, whether a substance is subject to special controls, or whether a substance may not be made available at all (“banned”).

The MCC may well have to reconsider its 2002 Complementary Medicines “call up” and issue another call up of products that are liable for registration, possibly based on their purported “use”, as Judge Zondi makes explicit. After six years there appears to have been little progress in either auditing or registering complementary medicines. There has instead been an explosion of products onto the market — and, as previously pointed out, no one is independently checking even the quality of these products, let alone the claims made. If what’s in a product is unknown, then clearly no statements can be made about its safety or efficacy. The medicines regulatory system in South Africa has unfortunately been an abysmal failure in controlling complementary medicines. According to Judge Zondi’s judgment, the MCC does not decide what is or is not a medicine. This is laid down in law. If someone is selling what they call a “nutritional supplement” which has any claimed medicinal use, and if they do not want it to be considered a medicine, they will have to go to court for a decision.

As far as the registration of complementary medicines goes, the DG seemingly pre-empted the judgment and the MCC’s decisions in November last year by telling the health portfolio committee that complementary medicines do not require registration.

What is the fuss about registration all about anyway? It’s really quite simple. It means that, in order to protect the public, an applicant who wants to register a medicine has to show that it meets requirements for quality, safety and efficacy. In other words evidence must be provided that the medicine contains only what the applicants claim it contains; that it has been shown to be safe in human beings at least in small scale studies; and that the medicine does what it is claimed it does. Just because a product is sold in a pharmacy or in a health shop does not necessarily mean that anyone has checked that the product meets any of these criteria. Registration also means that the scheduling, packaging, labelling, package insert, patient information leaflet and pricing all conform to the requirements in the Act.

If the judgment is taken to its logical conclusion and applied to the market, it surely means that every complementary medicine which makes any kind of medicinal claim in its advertising must now submit these claims to the MCC for review. The definition of “advertisement” would be that found in the Medicines Act. The judgment could also mean that the Advertising Standards Authority (ASA) does not in fact have the authority to make decisions about medicines’ advertising, as it is a function of the MCC in law. The ASA does not anyway have the medical or scientific capacity to assess claims made in medicines’ or health products’ advertising, so this ruling (if my interpretation is correct) should be welcomed.

The confounding factor in all this is that the Medicines and Related Substances Amendment Bill was introduced into parliament on 17 June 2008. If accepted, the MCC would be abolished and in its place a “health products regulatory authority” created. The amendment could possibly wipe the slate clean for the new regulatory authority by removing the accumulated six year backlog of tens of thousands of complementary medicines, the claims of which have not been reviewed. This is where Judge Zondi’s judgment may hold particular relevance. Does he, by implication, hold Minister Tshabalala-Msimang and DG Mseleku responsible for ensuring that advertising claims made for all medicines are submitted to the MCC for review? Is this possible in the MCC’s remaining lifespan, should the proposed amendment be passed? Could a concerted effort to determine the registrability of the complementary medicines on the market, and sufficient review of their claims, be the last great task (dying gasp?) of the MCC?

One of the most important changes of the amendment bill is that it would incorporate and regulate those foodstuffs and cosmetics that make “medicinal” or “health” claims. The proposed definition of a (health) product in the amendment bill appears to merely replace the word “medicine” with “product”. This broader definition would include “nutritional/dietary supplements” that make any health claim. The public should then benefit by knowing that any health claims made will have been reviewed to ensure that they are not false or misleading, and (finally!) be able to make an informed choice about their purchases. This is not the case at present, as no one is independently or proactively checking that all advertising claims for complementary medicines are neither false nor misleading.

It seems that all peddlars (unscrupulous or otherwise) of health products (dubious or otherwise) should in the mean time produce evidence for the claims made for their products and submit these to the MCC for review. The Minister should expedite this process. This could mean appointing assessors trained to scientifically evaluate the claims made, and who would then present their recommendations to the MCC. (This presupposes that for many products on the market such evidence even exists.) In addition, inspectors should be enabled to seize products that make advertising claims where these claims have not yet been reviewed by the MCC. If so, would ensuring this also be part of the Minister’s or DG’s responsibilities?

In summary, what is clear to me from the judgment is that authorisation is required in order to conduct a clinical trial; the definition of a medicine as stated in the Medicines Act cannot be decided by the MCC or anyone else but can only be disputed in court; and advertising claims of medicinal products should be reviewed by the MCC.

It is possible that Judge Zondi has done the citizens of our country a huge favour in tightening up the implementation of controls over medicines. Peddlars, no matter how smooth-talking, Ministers, DGs and inspectors are not above the law.

But a glaring unanswered question lingers — why was Lionel Snyman taken off the Rath case?

(These are my personal views and I do not speak for my present employers or as a former member of the Medicines Control Council. I have no working relationship with “Health-e news” whose excellent records I have drawn on, nor TAC who provided access to the judgment on their website, and I do not have any specific relationship with any part of the pharmaceutical industry.)

http://www.tac.org.za Nathan Geffen

This is an excellent analysis. The new Medicines and Related Substances Amendment Bill tabled on 17 June is, however, deeply problematic. It gives the Minister far too much power over what should essentially be a scientific technical task: determining the safety and efficacy of medicines. Under the new Bill, the Minister will have the power to determine if a medicine should be registered and to authorise the use of unregistered medicines. In other words, it opens the door even further for political interference in the regulation of medicines.

John Bond

A clear analysis of the Health Care Regulatory system Roy, thanks!

But does any of this matter? Our government has a reputation for flouting any outside intervention, no matter how critical so it’s just corrupt malevolence business as usual…

When do ARVs get distributed at our local rural KZN clinic?

Lebo

Oh my gosh. This is scary. Why is this article not on the front page?? Why has the Health Ministry been so slack about this issue. How can Rath be allowed to get away with this??

People??

Robin Grant

The fact that Dr Rath did not follow protocol does not change the fact that AIDS is curable.

I know several HIV positive people who’s AIDS has been reversed. AIDS and HIV are not the same thing. even though the medical industry likes to, and have for years, confused the issue to the point where your average man on the street does not distinguish between the two.
The simple truth is, good diet, and a healthy lifestyle can go a long way to strengthening an immune system. In fact it is recommended to those who suffer from HIV/AIDS by doctors. Fact: HIV is not curable at the moment, although anti-retroviral drugs can bring it under control.

The Health minister and the likes of Dr Rath are publicly mocked by representatives from the medical industry when diet and good nutrition are touted as a potential cure for AIDS. Lifestyle changes can reverse the Syndrome to the point where the immune system can resume normal functioning.

So in a sense it remains a pity that parties who are pursuing a more natural approach that is nutrition based as opposed to drug based for AIDS, are ridiculed so blatantly.

Zee

The amount of research, reasoned debate and reoprtage surrounding this issue is surprising.

Our Health Minister (bless her liver!) is a quack, promoting quack products, including “traditional medition” to a naive, uneducated and highly superstitious public.

FYI:
quack
–noun 1. a fraudulent or ignorant pretender to medical skill.
2. a person who pretends, professionally or publicly, to skill, knowledge, or qualifications she does not possess; a charlatan.
–adjective 3. being a quack: a quack psychologist who complicates everyone’s problems.
4. presented falsely as having curative powers: quack medicine.
5. of, pertaining to, or befitting a quack or quackery: quack methods.
–verb (used with object) 6. to treat in the manner of a quack.
7. to advertise or sell with fraudulent claims.

[Origin: 1620–30; short for quacksalver]

O Still small voice of calm

Note to Robin Grant:

If you think AIDS is curable, then I know of millions of people in South Africa (and worldwide), who would love to hear from you.

In fact you are in line for the Nobel prize, and a millionaire lifestyle besides.

Unless of course, you are another of these sad misguided people making money from the gullible, and the dying.

You say you “know several people whose AIDS has been reversed”. Yeah, right. My aunty Mabel smoked like a chimney till she was 93, so smoking does not realy give you cancer, right?

I have a barrel of snake-oil which I can sell you for a knock-down, price, cures everything you can think of, I swear!

Mink

This sounds like a perfectly reasonable analysis, Roy. My chief misgiving lies in the definition of ‘medical claims’ as made for complementary medicines and supplements. To illustrate with hyperbole, if a bottle of water claims to alleviate dehydration, does it need to be tested and registered with a government authority?

Hyperbole aside, it’s tempting to agree that every claim should be tested – but what will this process cost? A lot of perfectly valid ‘complementary medicines’ used successfully for centuries in non-allopathic systems like Ayurvedic medicine, homeopathy and phytotherapy (herbalism) are sold in insufficient quantities to justify expensive registration processes. Does this mean we should simply do without?

I have seen the wonderful results of antiretroviral drugs at first hand, and witnessed many of the miracles of modern medicine, but there’s a real danger in designing systems which exclude (intentionally or otherwise) other approaches to health care which don’t fit the all powerful – and frighteningly expensive – allopathic paradigm.

Surely the answer lies in treating consumers as adults – pointing out which medicines have undergone rigorous testing and registration, and those that haven’t, by means of compulsory labelling?

After all, if we’re allowed to buy a powerful carcinogenic drug like tobacco, with the sole proviso that it carries a health warning, why shouldn’t we be allowed to buy a vitamin pill with a label that says ‘the claims on this package have not been verified by the government – use at your own risk’?

http://letpeoplespeak.amagama.com Lyndall Beddy

“Thabo Mbeki’s legacy will largely be defined by his intransigence on the greatest public health threat facing South Africa -HIV/AIDS. In order to understand the gravity and sheer irresponsibility of Mbeki’s denialism we need only look at the evolution of a potentially manageable disease into a pandemic…….It is also important to document Mbeki’s record on HIV/AIDS in the light of attempts by his supporters to revise history.”
page 49 “To The Brink: The State of Democracy in South Africa” by Xolela Mangcu

doccie

Robin: What are you smoking? If nutrition was capable of reversing AIDS, then clearly no rich person on this planet will have it.
The major point you are missing is that Manto and Rath’s remedies must be subjected to the same stringent process that ARVs are. Ridiculous unsubstiated claims have already claimed the lives of many ignorant and vulnerable people desperate for a miracle.
I have yet to meet a Doctor who has promised his patients cure with ARVS. We make it absolutely clear that ARVS are are means to prolonging their life at best.

John Bond

@ Robin Grant
It’s time for you to do some research of your own!
Once an HIV person’s CD4 count has dropped below about 350, their immune system NEVER fully recovers. This is why one of the international measure for AIDS is a CD4 count of under 200.

Why not come to impoverished rural Kwa Zulu and spend a week visiting our local Kwa Dukuza or Mapumulo Hospitals. It’ll make your stomach churn. You’ll have to continuously remind yourself that those repulsive looking stick figures covered in sores were once humans. I suggest you bring a paper bag along so that when vomit, you can you retch into it…

– HIV causes AIDS and AIDS allows opportunistic disease to Kill the infected person
– A properly planned lifestyle including diet, exercise, control of stress and ARVs when needed can keep most HIV positive person alive almost indefinitely
– HIV Positive people are still just normal people and deserve to be treated as such
– Almost all HIV Positive people continue to contribute to our society, our country and the ANC government’s tax revenues until AIDS sets in. They deserve the highest level of support from this despotic government.

Let’s focus on the issues
The corrupt ANC government and dysfunctional Health Department must be forced to start providing for the masses of South Africans who are unable to provide for themselves.

Anthony Rees

Well, well, someone has dug a little deeper than all the lawyers, journalists and judge included. Well done!

My name is Anthony Rees. I used to work for Matthias Rath back in early 2004, when the Vitacell product was being conceptualized.

I was appointed as his local legislative policy adviser and was mandated to study and secure Vitacell’s legitimacy in the current regulatory framework.

Having been at the forefront of a fierce lobby battle to try convince the MCC and DOH to evaluate and regulate natural health substances on an evidence-based footing since 1996, I was deemed suitable qualified with expert knowledge in the field to undertake this task. Read up about PHARMAPACT if you don’t believe me.

Rath initially informed me at a boardroom briefing that Vitacel was going to be a general supplement for daily use by all and sundry, as part of an education outreach program to poor communities, and for them to better understand the role of nutrition in health. Never was it ever revealed with me that it had another intended use, which was to ‘reverse the course of Aids’.

In mid April 2004, Rath paid for a two day workshop at the MRC in CT in collaboration with Prof. Anthony Mbewu (current head of the MRC). This was to look at the feasibility of conducting clinical trials in collaboration with various universities, and the MRC as facilitators with reference to cardiovascular disease, cancer and diabetes. Something Rath claimed to be an expert in.

Initially the response of some local academics was positive and protocols were written up, but all fell apart when the MRC was set to receive a large EU investment injection.

At the time, Rath was under scrutiny for his questionable cancer claims in the EU, and immediately jumped to the conclusion that the funding was a means of the EU to quell his efforts in the developing world and to stop him conducting his life-saving research in the developing world where he would now focus his energies. SA would be a springboard to other threshold countries like Nigeria, India and Brazil, so he claimed.

Nevertheless, Rath immediately cut all ties with MRC, claiming it was a compromised institution, receiving funding from the pharma cartel, his enemy.

Rath then decided to swiftly change course and follow somewhat more revolutionary tactics to influence the powers that be to buy into his products, by following a multi-faceted route of approaching government leaders directly as one project and by creating a need at the ground level of the masses so great that people would demand his offerings from their government.

I personally flew up to Pretoria with the then, head of the SA office, Mr Chris Fairhurst to hand deliver Rath’s private letters to the Presidency at the Union Buildings in PTA and Manto’s office in Pretoria. The Parliamentary Health Portfolio Committee Chair, Mr James Ngculu was also visited on one occasion.

At that point, I was under the impression from all that was revealed to me that Vitacell would be a general vitamin supplement, much like the others on the open market, would be provided to locals at a low cost through telesales marketing at the Bree Street offices housed on the 15th floor of the Terraces Building.

A fulfillment company, named MailU in Diepriver would receive the orders from the call center in Bree St and then package and post the product on the buyers who would buy with credit cards. Telesales staff and financial controllers were appointed at the office and all was ready to go.

A shipment of Viatacell arrived via a courier named SAF Logistics and was impounded by Port Health, on the grounds that it was not classified / registered and that in their opinion we required a letter from the MCC to state its status.

Having discussed Vitacell with Rath on numerous occasions, I pointed out the current legislation with respect to both medicines and foodstuffs, so he could weigh up his options. After meticulously outlining the Medicines Control Act and the fact that he would be prohibited from making any associated claims on the product directly or indirectly without first establishing proof of efficacy, by means of clinical trials, he conceded to me that no claims were ever to be attached to the product as it was a merely a multi vitamin without any specific restorative purpose.

Having stated that as his sole intention, I in good faith truly believed that he would toe the line and conform to the local regulatory requirements.

After studying the MCC call-up notice of so-called ‘complimentary medicines’ of 2001, I established that Vitacell was not required to be listed under that notice firstly because the notice was only valid for products sold on or before, and more importantly within six months of the notice being promulgated. The introduction of Vitacell was 2 years after the notice expired. Secondly, the notice was for a mere ‘audit of the market’ and by admission of the MCC, NOT full registration. Thirdly I have never believed that the State should discriminate between Western and Eastern derived complimentary medicines and African Traditional Medicines. At the time the MCC was in my opinion acting unconstitutionally, by regulating one set of natural products, and blatantly ignoring others of African origin, which ARE the real problem in terms of safety. The fact remains that African Traditional Medicines is a leading cause of death in terms of all poisonings in SA. The State remains to turn a blind eye on this sector that cause up to 20,000 deaths per year.

I made contact with the deputy director of the Food Control Directorate of the DOH, Mrs Antoinette Booysen, explaining that Rath was intending to bring a multi vitamin preparation into SA with no associated claims and without any medical endorsement by a practitioner. After deliberating with her, she was of the opinion that because the levels of nutrients contained in the product were so low, and for the fact that no associated claims were being made for/on the product in marketing materials, keeping it out of the jurisdiction of the MCC, it was a merely foodstuff. One must note that the Food Contol directorate has had jurisdiction of nutrients and food components, and still does. Its when claims are associated to them or they become high dose, that the MCC takes over control.

I relayed to Rath the fact that the Food Control Directorate would be able to provide a letter to Port Health, in which it would state that Vitacell fulfilled the requirements as a food. This all under the strict proviso that it was not intended or made out to be intended to be a medicine.

Rath agreed to this. I then obtained a letter from the Food Control Directorate, declaring that in terms of their Act, it was a food.

Rath knew that if he crossed the line and made any claims for Vitacell, the food status would automatically fall away by default, and that he would be subject to the Medicines Act and the MCC. Something he should avoid.

On receiving the letter, passing it on to the port health authorities and import duties paid in full at SARS on the foreshore, the shipment was released and forwarded to MailU for sales and dispatch in late May.

Just after this I was relieved of my duties at Rath’s foundation under spurious grounds and I no longer had any association with Rath or his foundation. In fact, it was a relief.

A few months later I observed via the press with horror that Rath had been making claims for his Vitacell product and that he was conducting ‘clinical pilot studies’ utilizing Vitacell for Aids patients.

Being an evidence-based researcher and lecturer in the field of natural health products and their usage, I was astounded that a product with such low potency vitamins and other nutrients was being hailed as a panacea for ‘reversing the cause of Aids’ and it’s associated symptoms. I was appalled by the fact that Rath had broken his promise to me and Antoinette Booysen at the Food Control Directorate, and was now direct and deliberate in conflict with the Medicines Control Act, after having full understood the law and his limitations.

I felt sickened that I had been used an unsuspecting porn in his long-term strategy to market his products in SA. There is no doubt in my mind that Rath did intend to SELL Vitacell in South Africa with support from the highest ranks of our government, otherwise he would not have signed contracts with MailU and bought all the equipment, ordered and received 086 numbers and appointed staff to make sales over the phone from his offices in Bree Street.

He would also not have met with certain high ranking politicians and their spouses to attempt to procure land to build a factory to manufacture his products locally in an industrial estate just outside Muizenberg called Capricorn Park. Ask Ben Tourok (ANC MP), or Naledi Pandor’s husband.

Having followed this fiasco for the last few years and even being sued by Rath for defamation for saying it like it is, I was shocked when the director-General of the DOH made a statement in the recent High Court case that I had met their chief inspector, Andre Du Toit in person at the offices of the Rath Foundation in 2005. This was a lie and a gross fabrication. I was already out of the employ of Rath for a year when they allegedly begun their investigation. In fact, I have never met of spoken to Mr Andre Du Toit in my life. The mind boggles how these officials can purge themselves before a court of law to save their jobs..

It’s very clear to me that the DOH did nothing to investigate the matter when they were mandated to do so, upon many complaints. I admit that I did have a telephonic discussion with Lionel Snyman who contacted me along the lines of where the products could be found. I later called Snyman for a follow up briefing on the matter only to be informed that Andre Du Toit and Mrs Joey Gouws, his superior had been sitting with the dormant Rath complaints on their desks for over 8 months without any further investigation at all.

Inquiring whether there had been any intervention form the Minister’s office in this regard, he just scoffed and informed me that if orders come from the top they are followed without question. He informed me the that investigation had been pulled from his desk without explanation, and that he wanted to proceed against Rath but has his wings clipped by Du Toit and Joey Gouws. End case.

Well, I hope this puts things into better perspective for those who are trying to join the dots as to what really happened.

In conclusion to all this, I’m still at a loss of words as to why the DOH purged itself with regards to it’s inspector’s false statements before the court, and the lack of inquiry into the deaths of Rath’s star patients, after being hailed as normal and healthy.

What ever happened to poor Marietta Ndziba and others who stood up at Rath’s promotional gig before the world’s press, stating they were ‘well again’? She’s now six foot under, and we haven’t even had an explanation or an apology. Nothing….

With Rath please stand up!!

http://letpeoplespeak.amagama.com Lyndall Beddy

Anthony Rees

Thanks for your post.

Everyone Else

Vitamins do help health – but only WITH FOOD: carbohydrates, fats, protein are the building blocks of life.

John Bond

Yes Lyndall, as you say vitamins contained in foodstuffs do have a very important party to play in our health.

Occasionally, it is desirable to supplement some select, targeted vitamin or trace element by supplementation and, where possible this is done by eating a foodstuff rich in that particular vitamin or trace element.

Taking tablets should be a last resort. This is particularly true of our impoverished brothers. Consumption of some vitamin tablets in excessive quantity is counterproductive. In many other cases, we just don’t know whether the vitamin tablet has any effect whatsoever. Why take something that has no proven positive effect but may be harmful?

Omnivir is a medical device that generates humidified active oxygen in the form of a very energetic oxygen singlet (O) , pure oxygen (O2) and triatomic oxygen (O3, also known as medical ozone). Omnivir is used at home or clinics to care for HIV by reducing viral load, boosting immune and detoxifying the body.

How Active Oxygen works on HIV and Immune System:
Active Oxygen deactivates and eventually kills HIV by destroying its protective skin. Ozone’s destructiveness nature on HIV, virus and bacteria is partly attributed to the oxidation of unsaturated bonds in the phospholipids and lipoprotein architecture of the bacteria, viruses. The oxidation generates hydro peroxides, which are transformed to peroxyl and hydroxyl radicals and to other reactive species, including aldehydes. Peroxyl radicals attack proteins, and hydroxyl radicals induce disruptive structural changes in cell membranes. The reactive oxygen intermediates also contribute to the inactivation of viral reverse transcriptase. In order of preference, ozone reacts with polyunsaturated fatty acids (PUFA), antioxidants such as ascorbic and uric acids, thiol compounds with -SH groups such as cysteine, reduced glutathione (GSH) and albumin All of these compounds act as electron donor and undergo oxidation. Ozone reacts with body fluids forming moles of hydrogen peroxide (included among reactive oxygen species, ROS) and moles of lipid oxidation products (LOPs) The fundamental ROS molecule is hydrogen peroxide, which is a non-radical oxidant able to act as an ozone messenger responsible for eliciting several biological and therapeutic effects. Hydrogen Peroxide already exists in human cells and its the key chemical on fighting infections, e.g. viruses and bacteria. The ozone bio-oxidative process is therefore characterized by the formation of ROS and LOPs acting in two phases. ROS are acting immediately and disappear (early and short-acting messengers), LOPs, via the circulation, distribute throughout the tissues and eventually only a few molecules bind to cell receptors . In fact of ozone returns to normal within half an hour and the oxidized compounds such as dehydroascorbate are efficiently recycled back to ascorbic acid. H2O2 diffuses easily from the plasma into the cells and its sudden appearance in the cytoplasm represents the triggering stimulus: depending upon the cell type, different biochemical pathways can be concurrently activated in erythrocytes, leukocytes and platelets resulting in numerous biological effects.

At right concentration, medical ozone kills 99.999% lipid viruses and bacteria in the tests tube, water and in the air. Here is a list of opportunistic pathogens susceptible to the antiviral and antibacterial power of ozone therapy: herpes viridae, simplex, varicella-zoster, kaposi sarcoma, epstein – barr, influenza, hepatitis.

Ozone also acts as an enhancer of the immune system by activating neutrophils and stimulating the synthesis of some cytokines. The by product of ozone, hydrogen peroxide, which after entering into the cytoplasm of blood mononuclear cells (BMC) by oxidizing selected cysteines, activates a tyrosine kinase, which then phosphorylates the transcription factor nuclear factor κB allowing the release of a heterodimer (p50+p65). This complex moves on to the nucleus and switches on some hundred genes eventually responsible for causing the synthesis of several proteins, among which are the acute-phase reactants and numerous interleukins. Once the ozonated leukocytes return to the circulation, they home in lymphoid microenvironments and successively release cytokines acting in a paracrine fashion on neighbouring cells with a possible reactivation of a depressed immune system.

Active Oxygen Success on HIV/AIDS:
This medical gas has been in use for a long time mostly in hospitals and by physicians across the world. Physicians report 99.9% success rate on HIV patients, also remission of the condition in most cases. Doctors across the world claims to have cured HIV on more than 500 patients using a rigorous and very expensive ($25,000) protocol which included Active Oxygen IV Therapy as the main treatment. There are more than 5 US and International patents for research to cure HIV using active oxygen/ozone, none have been put on the market due to production and regulatory costs.

Ozone (O3) is a toxic, oxidant (free radical) pollutant, and exposure has been shown to induce antioxidant depletion and be a cause of oxidation, thereby increasing the risk of cancer and other oxidative stress disorders.

When ozone is introduced into blood, it reacts with water in red blood cells, producing hydrogen peroxide. This aqueous decomposition of ozone also produces bactericidal and membrane-damaging free radicals.

All of these effects are NOT what one needs if one is HIV-positive. In fact, long term use will be deleterious to overall health.

You state: ‘medical ozone kills 99.999% lipid viruses and bacteria in the tests tube, water and in the air’. What happens in a petri dish or test tube can happen with any solvent or chemical at the right concentration.

Therefore such statements are misleading and circulated to create hype among the scientific illiterate.

Use of ozone in the alleged treatment of HIV/Aids is pure quackery and unsubstantiated by evidence-based science.

You may argue that I’m some sort of drug cartel agent attempting to dissuade people from natural medicine. To the contrary, I am a Naturopath who seeks to further investigate natural health strategies to optimise health with an evidence-based approach.

With respect to the subject at hand, the evidence isn’t very forthcoming, despite many anecdotal claims and ozone industry funded publications.

Roy

@pings

The point of my initial blog was to focus on the Zondi judgement. The exact same rationale can be used for an unregistered medical device. The advertising claims should be reviewed by the MCC. Dumping advertorial into a blog is also advertising, but I’m pretty sure that “Omnivir” has not been reviewed by the MCC.

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Roy Jobson is a specialist medical doctor in clinical pharmacology. He is employed as a specialist clinical pharmacologist at the Dr George Mukhari Academic Hospital / Associate Professor of Pharmacology at the Sefako Makgatho Health Sciences University. He is a Council member of the Allied Health Professions Council of South Africa. In his non-medical life, he is a vicarious observer of South African society through his association with the Khulumani Support Group, where his wife is the director. He has done extensive research in the last few years on the advertising and marketing of medicines in South Africa - with an emphasis on complementary medicines.